title: A randomized, double-blind, placebo-controlled trial of ormeloxifene in breast pain and nodularity.
abstract: BACKGROUND
  Breast pain and non-discrete breast nodularity are common in women.
  
  
  METHODS
  We did a randomized, double-blind, placebocontrolled trial of oral ormeloxifene 30 mg, a selective oestrogen receptor modulator (SERM) or placebo twice a week for 3 months in 20-50-year-old women with breast pain with or without lumpiness. Women with a discrete benign lump or cancer were excluded from the study. Serial assessments of pain on a visual analogue scale and nodularity grade on a 5-point ordinal Lucknow-Cardiff scale were done. A total of 151 patients were randomly allocated to two interventions using a block size of 4.
  
  
  RESULTS
  Of the 151 patients, 121 (active 57, placebo 64) were available for efficacy analysis. The mean pain level showed a systematic downward trend over five visits (F=105.23, p<0.0001) that significantly reduced in the active group compared to that in the placebo group (F=18.66, p<0.0001). The patterns of variation in pain over time for the individual groups differ from the overall mean pattern for the two groups and thus from one another (F=44.43, p<0.0001). Cumulative frequencies of breast nodularity grades during successive visits showed significant improvement (p=0.001) compared to placebo at the end of the third month. The effect of the active drug persisted till the completion (6 months) of treatment (p<0.001). At the last visit, 93.3% of women in the active group had grade 2 or lower nodularity as compared to 71.1% in the placebo group. Oligomenorrhoea alone was reported by 12 patients.
  
  
  CONCLUSIONS
  Ormeloxifene showed significant efficacy for treating breast pain and nodularity.
authors.affiliation: King George's Medical University, Lucknow 226003, Uttar Pradesh, India. Department of Surgery.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Kumar
authors.forename: Ruchi
authors.initials: R
authors.lastname: Rai
authors.forename: G G
authors.initials: GG
authors.lastname: Agarwal
authors.forename: Varsha
authors.initials: V
authors.lastname: Dwivedi
authors.forename: Surender
authors.initials: S
authors.lastname: Kumar
authors.forename: Vinita
authors.initials: V
authors.lastname: DAS
mesh_terms: D000328:Adult; D001578:Benzopyrans / Q000627:therapeutic use*; D001940:Breast / Q000473:pathology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D059373:Mastodynia / Q000188:drug therapy* / Q000473:pathology*; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use*
chemical_list: D001578:Benzopyrans; D020845:Selective Estrogen Receptor Modulators; C508548:ormeloxifene